THC (Medical Cannabis)

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THC (Medical Cannabis) Clinical Pharmacology The human body has an endogenous cannabinoid (endocannabinoid) system composed of two G-protein coupled receptors (CB1 and CB2), two ligands (anandamide and 2-arachidonylglycerol (2-AG)) and several regulatory enzymes. Most of the biological properties attributed to phytocannabinoids are dependent on their interactions with the endocannabinoid system in humans. There is evidence the endocannabinoid system modulates or regulates various types of physiological processes.

Phytocannabinoids are naturally occurring chemical compounds found within the flowers of the cannabis plant. Currently, more than 100 different phytocannabinoids have been discovered, but only a few of the major ones have been characterized in depth, primarily delta-9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD).

Δ9-THC is one of the most studied and important cannabinoids in the cannabis plant and is responsible for many effects in animals and humans. THC is a partial agonist of both CB1 and CB2 receptors but has higher affinity for the CB1 receptor. In addition to being present in the central nervous system and throughout the brain (and likely responsible for the psychoactive effects of THC), CB1 receptors are also found in the immune cells and the gastrointestinal, reproductive, adrenal, heart, lung and bladder tissues, where cannabinoids can also exert their activities. CB2 receptors are primarily found in the immune system and are thought to have immunomodulatory effects and to regulate cytokine activity.

Cannabidiol (CBD) is the major non-psychotropic cannabinoid found in cannabis. CBD exhibits many pharmacological properties and has been shown in vitro and in animal studies to possess anti-anxiety, anti-nausea, anti-arthritic, anti-epileptic, anti-psychotic, anti-inflammatory, neuroprotective and immunomodulatory properties. It has also shown potential in preclinical models of central nervous system diseases such as epilepsy, neurodegenerative diseases, schizophrenia, multiple sclerosis, affective disorders and the central modulation of feeding behavior.

Indications and Use In Florida, a patient must be diagnosed with at least one of the following conditions to qualify to receive marijuana or a marijuana delivery device:

• Cancer. • Epilepsy. • Glaucoma. • Positive status for human immunodeficiency virus. • Acquired immune deficiency syndrome. • Post-traumatic stress disorder. • Amyotrophic lateral sclerosis. • Crohn’s disease. • Parkinson’s disease. • Multiple sclerosis. • Medical conditions of the same kind or class as or comparable to those listed above. • A terminal condition diagnosed by a physician other than the qualified physician issuing the physician certification. • Chronic nonmalignant pain. Chronic nonmalignant pain means pain that is caused by a qualifying medical condition or that originates from a qualifying medical condition and persists beyond the usual course of that qualifying medical condition

Dosage and Administration THC Dosing Recommendations: Due to a wide range of strains and cannabinoid ratios used in clinical studies, usually allowing dosage titration to effect, standard dosage recommendations are difficult to establish.

Primarily because cannabinoid receptors are not located in the brainstem areas controlling respiration, a lethal overdose from cannabis has not been documented. The active dose is very far below any potential lethal dose. However, a narrow index may exist between desired medical benefit and undesirable adverse effects.

A maximum dose will depend on various factors including but not limited to: cannabis experience, tolerance, other existing medical conditions, adverse effects, drug interactions, variability in how patients metabolize the compounds, and strain and cannabinoid ratios.

Patients should work closely with their physician to determine the dosage that works best for each individual. Starting doses should be small and titration should proceed slowly to prevent or minimize undesirable adverse effects.

Time of Onset of Effects Time of Peak Effects Duration of Effect 90 – 120 minutes 2 – 6 hours 4 – 12 hours

Initial dosing recommendations were established based on the potential for side effects and the importance of starting low and going slow.

ORAL dosing frequency: Re-dosing of orally administered cannabis should be based on the fact that individuals who ingest cannabis may not begin to experience psychoactive or physiological effects for 120 minutes after ingestion. Due to this delay in onset, close observation of any potential side effects is recommended prior to re-dosing. Oral cannabis could potentially be administered between 1-3 times per day. THC Cannabis Concentrates: The amount of THC in this product is very concentrated. Each 0.1mL increment contains approximately 70mg- 95 mg of active THC cannabinoid. There is the potential for impaired concentration, coordination and judgment. Keep out of reach of children. Starting doses should be small and titration should proceed slowly to prevent or minimize undesirable adverse effects.

Vaporizer Dosing Recommendations Time of Onset of Effects Time of Peak Effects Duration of Effect 90 seconds 15 – 30 minutes 2 – 3 hours

Initial dosing recommendations were established based on the potential for side effects and the importance of starting low and going slow.

VAPORIZER dosing frequency: Due to the fast onset of action and shorter duration of effects (compared to the oral route of administration), vaporized cannabis may be administered up to 4-6 times per day. However, close observation of any potential side effects is recommended prior to increasing the number of inhalations per dose and the frequency of dosing.

Each 1- 2 second vaporized inhalation typically delivers approximately 1- 3 mg of Total Active Cannabinoid.

Multiple variables can potentially affect the amount of mg delivered per inhalation. These variables include battery charge and strength and length of inhalation. This is a limitation with vaporization pen delivery systems, and we recommend patients to recharge their batteries after every 20 inhalations. We recommend that the patient inhale for one second with button-activated batteries, hold vapor for five seconds, exhale, and then repeat it again at 90 seconds.

**When vaporizing raw cannabis material, inhalation volume changes with phase, tending to be highest at the beginning and lowest at the end, therefore, an exact mg per inhalation is difficult to determine. Inhalation volume also differs by experience with more frequent users having larger inhalation volumes and less frequent users having smaller inhalation volumes. Therefore, each inhalation delivers a discrete dose of cannabinoids to the body.

Whole Flower Dosing Recommendations Time of Onset of Effects Time of Peak Effects Duration of Effect 90 seconds 15 – 30 minutes 2 – 3 hours

Initial Dosing recommendations were established based on the potential for side effects and the importance of starting low and going slow.

Whole Flower Dosing Frequency: Due to the fast onset of action and shorter duration of effects (compared to the oral route of administration), vaporized or smokable cannabis may be administered up to 4-6 times per day. However, close observation of any potential side effects is recommended prior to increasing the number of inhalations per dose and the frequency of dosing.

Whole Flower for Vaporization** Natural flower product used for vaporization provides whole plant benefits, also known as the entourage effect, without the unwanted carcinogens or toxins associated with smoking cannabis which may negatively affect health. The product is available in THC-dominant strain and in a CBD-dominant strain (>0.8% THC). Batch strengths and CBD:THC ratios will vary. Each strain contains a %CBDa and %THCa and corresponding mg of CBDa and THCa (converted to THC and CBD, respectively when heated during vaporization). Once the full content of the package size has been utilized, the full amount of mg of CBD and THC will have been delivered. Only the amount of THC counts towards the patient’s allotment in the MMUR.

Whole Flower for Smoking** Natural flower product used for smoking. It provides whole plant benefits, also known as the entourage effect. Smoke contains carcinogens and may negatively affect health. This product is available in THC-dominant strains and CBD- dominant (>0.8%THC) strains. Batch strengths and CBD:THC ratios will vary. Each strain contains a %CBDa and %THCa and corresponding mg of CBDa and THCa (converted to THC and CBD, respectively when heated during vaporization). Once the full content of the package size has been utilized, the full amount of mg of CBD and THC will have been delivered. Only the amount of THC counts towards the patient’s allotment in the MMUR.

**When vaporizing or smoking raw cannabis material, inhalation volume changes with phase, tending to be highest at the beginning and lowest at the end, therefore, an exact mg per inhalation is difficult to determine. Inhalation volume also differs by experience with more frequent users having larger inhalation volumes and less frequent users having smaller inhalation volumes. Therefore, each inhalation delivers a discrete dose of cannabinoids to the body.

Topical Cannabis Dosing Recommendations Time of Onset of Effects Time of Peak Effects Duration of Effect 90 – 120 minutes 2 – 6 Hours 4 – 12 hours

Topical forms are typically used as creams or lotions to treat localized pain and discomfort. Cannabis and cannabinoids are hydrophobic and do not penetrate the skin easily. Although there is a possibility of some delivery to the bloodstream, the primary effect of this product is topical as it interacts with cannabinoid receptors directly on the skin.

Apply only to clean, dry, intact skin and must not apply to eyes, mucous membranes, or open wounds. Wash hands before and after use and should not shower or bathe for at least 30 minutes after applying.

Dosage Forms and Strengths: Curaleaf produces multiple formulations of THC using different ratios of CBD:THC to take advantage of the varying ways cannabinoids (the most important active compounds of the cannabis plant) work together to exert their effects.

• THC Oil Ingredients: Natural Cannabis Oil, Non-GMO Safflower Oil. Available in CBD:THC 1:1, CBD:THC 1:10 and CBD:THC 0:1 • THC Tincture Ingredients: Natural Cannabis Oil, Natural Flavors, MCT Oil. Available in CBD:THC 0:1, CBD:THC 1:1 • THC Capsules Ingredients: Natural Cannabis Oil, Microcrystalline Cellulose, Gelatin Capsule. Available in CBD:THC 1:1, CBD:THC 1:10 and CBD:THC 0:1 • THC Tablets Ingredients: Cannabis Extract, Sorbitol, Polyvinylpyrrolidone (PVP), Vitamin E, Menthol, Spearmint Flavoring, Magnesium Stearate, and Titanium Dioxide. Available in CBD:THC 0:1 • THC Sublingual Tablets Ingredients: Sorbitol Syrup, Maltitol, Water, Hydrolyzed Collagen, Citric Acid, Flavor, Cannabis Extract, Sucralose. Available in CBD:THC 0:1 • THC Vaporizer Pen Oil Ingredients (including Select Elite): Natural Cannabis Oil, Natural Terpenes. Available in CBD:THC 1:1 , CBD:THC 1:10 and CBD:THC 0:1 • Select THC Live Resin Vaporizer Pen Oil Ingredients: Natural Cannabis Oil, Cannabis-derived Terpenes. Available in CBD:THC 1:1 , CBD:THC 1:10 and CBD:THC 0:1 • THC Vaporizer Slim Pen Oil Ingredients: Natural Cannabis Oil, Natural Terpenes. Available in CBD:THC 0:1 • Topical Balm: Ingredients: Natural Cannabis Oil, Coconut Oil, Cocoa Butter. Available in CBD:THC 0:1 and CBD:THC 1:1 • Concentrates: Distillate: 0:1 CBD:THC Pure THC distillate with no cutting agents. THC Concentrate ingredients include distilled natural THC–rich cannabis oil. Batch strengths will vary between 80% - 95% (400mg – 475mg THC/ 0.5mL syringe).

RSO: 0:1 CBD:THC Full Extract Cannabis Oil. Batch strengths will vary between 60% - 95% (600mg – 950mg THC/ 1.0 mL syringe).

CO2 THC CONCENTRATE 0:1 CBD:THC Natural THC oil made from the dewaxed plant extract with no cutting agent. Batch strengths will vary between 70% - 85% (350mg – 425mg THC/0.5mL syringe)

THC CONCENTRATE 0:1 CBD:THC - CRUMBLE: with no cutting agents. THC Crumble ingredients include natural THC–rich cannabis oil. Batch strengths will vary between 60% - 95% THCa (526 mg – 833 mg THC/ 1-gram package size).

• Whole Flower – 3.5g, 7.0 g, 14.17 g, 28.35 g Total Flower weight. – Natural flower product used for smoking. It provides whole plant benefits, also known as the entourage effect. Smoke contains carcinogens and may negatively affect health. This product is available in THC-dominant strains and CBD- dominant (>0.8%THC) strains. Batch strengths and CBD:THC ratios will vary.

• Prerolled Marijuana Cigarettes – 0.8 g, 1.0 g, 2.0 g, 3.0 g Total Flower weight. – Natural flower product used for smoking. It provides whole plant benefits, also known as the entourage effect. Smoke contains carcinogens and may negatively affect health. This product is available in THC-dominant strains and CBD- dominant (>0.8%THC) strains. Batch strengths and CBD:THC ratios will vary. Descriptions: 1:10 CBD:THC Hybrid Oil, Capsules , Vaporizer Pen Oil (including Select Elite) , Select Live Resin Vaporizer Pen Oil The 1:10 formulation is a THC dominant ratio recommended for qualified patients who respond to the therapeutic actions of THC for their condition. Available in oral oil, oral capsules, and vaporizer pen oil.

1:1 CBD:THC Hybrid Oil, Capsules, Vaporizer Pen Oil (including Select Elite), Topical Balm, Whole Flower, Prerolled Marijuana Cigarettes, Live Resin Vaporizer Pen Oil The balanced 1:1 formulation is recommended for qualified patients who respond to the therapeutic actions of both THC and CBD. This ratio may reduce the psychoactive effects of THC. Available in oral oil, oral capsules , vaporizer pen oil, topical balm, whole flower, and Prerolled Marijuana Cigarettes.

0:1 CBD:THC Oil, Capsules, Vaporizer Pen Oil (including Select Elite), Concentrate, Tablets, Sublingual Tablets, Tincture, Topical Balm, Whole Flower, Prerolled Marijuana Cigarettes, Live Resin Vaporizer Pen Oil The 0:1 formulation is a pure THC product recommended for qualified patients who respond to the therapeutic actions of THC for their condition. Available in oral oil, oral capsules, vaporizer pen oil, concentrates, tablets, sublingual tablets, tincture, topical balm, whole flower, and Prerolled Marijuana Cigarettes.

0:1 CBD:THC Vaporizer Pen Oil (including Select Elite) & Select Live Resin Vaporizer Pen Oil Available in 60% (300 mg THC), 70% (350 mg THC), 75% (375 mg THC), 80% (400 mg THC), 85% (425 mg), 90% (450 mg) and 95% (475 mg) and in various strains (0.5 g size). Available in 60% (600 mg THC), 70% (700 mg THC), 75% (750 mg THC), 80% (800 mg THC), 85% (850 mg), 90% (900 mg) and 95% (950 mg) and in various strains (1.0 g size).

0:1 CBD:THC Capsules • 10 mg THC – Indica and Sativa • 50mg THC- Hybrid

0:1 CBD:THC Tablets • 5 mg THC – Indica and Sativa • 5 mg THC – Hybrid

0:1 CBD:THC Sublingual Tablets • 5 mg THC – Indica and Sativa • 5 mg THC – Hybrid

0:1 CBD:THC Oil • 10mg THC/mL – Indica and Sativa

0:1 CBD:THC Concentrates from distillate- Hybrid Batch strengths will vary: • 75% (375mg THC)- per 0.5mL syringe • 90% (450mg THC)- per 0.5mL syringe • 80% (400mg THC)- per 0.5mL syringe • 95% (475mg THC)- per 0.5mL syringe

0:1 CBD:THC RSO Batch strengths will vary: • 60% (600mg THC)- per 1.0 mL syringe • 80% (800 mg THC)- per 1.0 mL syringe • 65% (650mg THC)- per 1.0 mL syringe • 85% (850 mg THC)- per 1.0 mL syringe • 70% (700mg THC)- per 1.0 mL syringe • 90% (900mg THC)- per 1.0 mL syringe • 75% (750 mg THC)- per 1.0 mL syringe • 95% (950mg THC)- per 1.0 mL syringe

0:1 CBD:THC CO2 Concentrates from dewaxed plant extract- Indica and Sativa Batch strengths will vary: • 70% (350mg THC)- per 0.5mL syringe • 80% (400mg THC)- per 0.5mL syringe • 75% (375mg THC)- per 0.5mL syringe • 85% (425mg THC)- per 0.5mL syringe

THC CONCENTRATE 0:1 CBD:THC - SHATTER: with no cutting agents. THC Shatter ingredients include natural THC–rich cannabis oil. Batch strengths will vary between 60% - 95% THCa (526 mg – 833 mg THC/ 1-gram package size). • 60%(526 mg THC)- per 1 g package • 80% (702mg THC)- per 1 g package • 65% (570 mg THC)- per 1 g package • 85% (745 mg THC)- per 1 g package • 70% (614 mg THC)- per 1 g package • 90% (789 mg THC)- per 1 g package • 75% (658 mg THC)- per 1 g package • 95% (833 mg THC)- per 1 g package

THC CONCENTRATE 0:1 CBD:THC - WAX: with no cutting agents. THC Wax ingredients include natural THC–rich cannabis oil. Batch strengths will vary between 60% - 95% THCa (526 mg – 833 mg THC/ 1-gram package size). • 60%(526 mg THC)- per 1 g package • 80% (702mg THC)- per 1 g package • 65% (570 mg THC)- per 1 g package • 85% (745 mg THC)- per 1 g package • 70% (614 mg THC)- per 1 g package • 90% (789 mg THC)- per 1 g package • 75% (658 mg THC)- per 1 g package • 95% (833 mg THC)- per 1 g package

THC CONCENTRATE 0:1 CBD:THC - CRUMBLE: with no cutting agents. THC CRUMBLE ingredients include natural THC–rich cannabis oil. Batch strengths will vary between 60% - 95% THCa (526 mg – 833 mg THC/ 1-gram package size). • 60%(526 mg THC)- per 1 g package • 80% (702mg THC)- per 1 g package • 65% (570 mg THC)- per 1 g package • 85% (745 mg THC)- per 1 g package • 70% (614 mg THC)- per 1 g package • 90% (789 mg THC)- per 1 g package • 75% (658 mg THC)- per 1 g package • 95% (833 mg THC)- per 1 g package

THC CONCENTRATE 0:1 CBD:THC – Live Resin: with no cutting agents. THC Live Resin ingredients include natural THC–rich cannabis oil and Cannabis-derived Terpenes. Batch strengths will vary between 60% - 95% THCa (526 mg – 833 mg THC/ 1-gram package size). • 60%(526 mg THC)- per 1 g package • 80% (702mg THC)- per 1 g package • 65% (570 mg THC)- per 1 g package • 85% (745 mg THC)- per 1 g package • 70% (614 mg THC)- per 1 g package • 90% (789 mg THC)- per 1 g package • 75% (658 mg THC)- per 1 g package • 95% (833 mg THC)- per 1 g package

1:10 CBD:THC Oil Capsules Vaporizer Pen Oil 10 mg 10 mg THC/mL 5 mg capsule 10 mg capsule 300 mg cartridge Concentration THC/mL Package Size 30 mL 60 mL 30 count 30 count 1 cartridge Total THC 300 mg 600 mg 150 mg 300 mg 300 mg (per unit) Total CBD (per unit) 30 mg 60 mg 15 mg 30 mg 30 mg

1:1 CBD:THC (1) Oil Capsule Vaporizer Pen Oil Topical Balm 5 mg CBD and 150 mg CBD and 5 mg CBD and 5mg THC 150 mg CBD and Concentration 5mg THC 150 mg THC per mL 150 mg THC per jar per capsule per cartridge Package Size 60 mL 30 count 1 cartridge 1 jar Total THC 300 mg 150 mg 150 mg 150 mg (per unit) Total CBD 300 mg 150 mg 150 mg 150 mg (per unit) Total Active 600 mg 300 mg 300 mg 300 mg (per unit)

0:1 CBD:THC (1) Vaporizer Pen Oil (including Select Elite) – 0.5 g

Concentration 60% 70% 75% 80% 85% 90% 95% 1 1 1 1 1 1 1 Package Size cartridge cartridge cartridge cartridge cartridge cartridge cartridge Total THC 300 mg 350 mg 375 mg 400 mg 425 mg 450 mg 475 mg (per unit)

0:1 CBD:THC (2) Vaporizer Pen Oil (including Select Elite) – 1.0 g

Concentration 60% 70% 75% 80% 85% 90% 95%

1 1 1 1 1 1 1 Package Size cartridge cartridge cartridge cartridge cartridge cartridge cartridge Total THC 600 mg 700 mg 750 mg 800 mg 850 mg 900 mg 950 mg (per unit)

0:1 CBD:THC (3) Select Live Resin Vaporizer Pen Oil (0.5 g)

0:1 CBD:THC (4) Select Live Resin Vaporizer Pen Oil (1.0 g)

Concentration 60% 70% 75% 80% 85% 90% 95% 1 1 1 1 1 1 1 Package Size cartridge cartridge cartridge cartridge cartridge cartridge cartridge Total THC 600 mg 700 mg 750 mg 800 mg 850 mg 900 mg 950 mg (per unit)

0:1 CBD:THC (5) Capsules Slim Vaporizer Pen Oil

Concentration 10 mg 50 mg 65% 70% 75% 80% 85% 90% 95%

30 10 Package Size 1 cartridge 1 cartridge 1 cartridge 1 cartridge 1 cartridge 1 cartridge 1 cartridge count count Total THC 300 500 285 mg 307 mg 329 mg 351 mg 373 mg 395 mg 417 mg (per unit) mg mg

0:1 CBD:THC (6) Sublingual Oil Tablets Tincture Topical Balm Tablets Concentration 10 mg/mL 5 mg 5 mg 10 mg/mL 300 mg 30 Package Size 60 mL 30 count 60 mL 1 jar count Total THC 600 mg 150 mg 150 mg 600 mg 300 mg (per unit)

0:1 CBD:THC Concentrates from distillate- Hybrid Concentration Total Amount of THC per unit Package size 75% 375 mg 0.5mL syringe 80% 400 mg 0.5mL syringe 85% 425 mg 0.5mL syringe 90% 450 mg 0.5mL syringe 95% 475 mg 0.5mL syringe

0:1 CBD:THC RSO Concentration Total Amount of THC per unit Package size 60% 600 mg 1.0 mL syringe 65% 650 mg 1.0 mL syringe 70% 700 mg 1.0 mL syringe 75% 750 mg 1.0 mL syringe 80% 800 mg 1.0 mL syringe 85% 850 mg 1.0 mL syringe 90% 900 mg 1.0 mL syringe 95% 950 mg 1.0 mL syringe

0:1 CBD:THC THC CO2 Concentrates from dewaxed plant extract - Indica and Sativa

Concentration Total Amount of THC per unit Package size 70% 350 mg 0.5mL syringe 75 % 375 mg 0.5mL syringe 80% 400 mg 0.5mL syringe 85% 425 mg 0.5mL syringe 90% 450 mg 0.5mL syringe

THC Concentrates* --- SHATTER THC Concentrates* --- WAX %THCa Total THC mg per 1 g package %THCa Total THC mg per 1 g package 60% 526 mg 60% 526 mg 65% 570 mg 65% 570 mg 70% 614 mg 70% 614 mg 75% 658 mg 75% 658 mg 80% 702 mg 80% 702 mg 85% 745 mg 85% 745 mg 90% 789 mg 90% 789 mg 95% 833 mg 95% 833 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

THC Concentrates* --- CRUMBLE THC Concentrates* --- Live Resin %THCa Total THC mg per 1 g package %THCa Total THC mg per 1 g package 60% 526 mg 60% 526 mg 65% 570 mg 65% 570 mg 70% 614 mg 70% 614 mg 75% 658 mg 75% 658 mg 80% 702 mg 80% 702 mg 85% 745 mg 85% 745 mg 90% 789 mg 90% 789 mg 95% 833 mg 95% 833 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

THC Dominant Flower* (3.5 g total flower weight) THC Dominant Flower* (14.17 g total flower weight) Total THC mg Total THC mg %THCa %THCa per 3.5 g Flower per 14.17 g Flower 12.5% 384 mg 12.5% 1553 mg 15% 462 mg 15% 1864 mg 17.5% 536 mg 17.5% 2178 mg 20.0% 613 mg 20.0% 2485 mg 22.5% 690 mg 22.5% 2796 mg 25.0% 767 mg 25.0% 3107 mg 27.5% 844 mg 27.5% 3417 mg 30.0% 921 mg 30.0% 3728 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

THC Dominant Flower* (7.0 g total flower weight) THC Dominant Flower* (28.35 g total flower weight) Total THC mg Total THC mg %THCa %THCa per 7.0 g Flower per 28.35 g Flower 12.5% 767 mg 12.5% 3108 mg 15% 921 mg 15% 3729 mg 17.5% 1074 mg 17.5% 4351 mg 20.0% 1228 mg 20.0% 4973 mg 22.5% 1381 mg 22.5% 5594 mg 25.0% 1535 mg 25.0% 6215 mg 27.5% 1688 mg 27.5% 6837 mg 30.0% 1842 mg 30.0% 7459 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

CBD Dominant Flower (>0.8% THC *) (3.5 g total flower weight) CBD Dominant Flower (>0.8% THC *) (7.0 g total flower weight) Total CBD mg Total CBD mg %CBDa %CBDa per 3.5 g Flower per 7.0 g Flower 10% 308 mg 10% 616 mg 12.5% 385 mg 12.5% 770 mg 15% 462 mg 15% 924 mg 17.5% 539 mg 17.5% 1078 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

CBD Dominant Flower (>0.8% THC *) (14.17 g total flower weight) CBD Dominant Flower (>0.8% THC *) (28.35 g total flower weight) Total CBD mg Total CBD mg %CBDa %CBDa per 3.5 g Flower per 7.0 g Flower 10% 1247 mg 10% 2495 mg 12.5% 1559 mg 12.5% 3119 mg 15% 1870 mg 15% 3742 mg 17.5% 2182 mg 17.5% 4366 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

THC Dominant Prerolls* (0.8 g total flower weight/preroll) THC Dominant Prerolls* (1.0 g total flower weight/preroll) Total THC mg Total THC mg %THCa %THCa per 1.0 g Flower per 1.0 g Flower 12.5% 88 mg 12.5% 110 mg 15.0% 105 mg 15.0% 132 mg 17.5% 123 mg 17.5% 153 mg 20.0% 140 mg 20.0% 175 mg 22.5% 158 mg 22.5% 197 mg 25.0% 175 mg 25.0% 219 mg 27.5% 193 mg 27.5% 241 mg 30.0% 210 mg 30.0% 263 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

THC Dominant Prerolls* (2.0 g total flower weight/preroll) THC Dominant Prerolls * (3.0 g total flower weight) Total THC mg Total THC mg %THCa %THCa per 2.0 g Flower per 3.0 g Flower 12.5% 219 mg 12.5% 329 mg 15.0% 263 mg 15.0% 395 mg 17.5% 307 mg 17.5% 460 mg 20.0% 351 mg 20.0% 526 mg 22.5% 395 mg 22.5% 592 mg 25.0% 439 mg 25.0% 658 mg 27.5% 482 mg 27.5% 724 mg 30.0% 526 mg 30.0% 789 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

CBD Dominant Prerolls (>0.8% THC *) (0.8 g total flower weight) CBD Dominant Prerolls (>0.8% THC *) (1.0 g total flower weight) Total CBD mg Total CBD mg %CBDa %CBDa per 1.0 g Flower per 1.0 g Flower 10% 70 mg 10% 88 mg 12.5% 88 mg 12.5% 110 mg 15% 106 mg 15% 132 mg 17.5% 123 mg 17.5% 154 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

CBD Dominant Prerolls (>0.8% THC *) (2.0 g total flower weight) CBD Dominant Prerolls (>0.8% THC *) (3.0 g total flower weight) Total CBD mg Total CBD mg %CBDa %CBDa per 2.0 g Flower per 3.0 g Flower 10% 176 mg 10% 264 mg 12.5% 220 mg 12.5% 330 mg 15% 264 mg 15% 396 mg 17.5% 308 mg 17.5% 462 mg *Batch strengths and CBD:THC ratios will vary. *Batch strengths and CBD:THC ratios will vary.

Contraindications Absolute contraindications: Acute psychosis and other unstable psychiatric conditions; serious hypersensitivity to cannabis, or any component of the THC formulation.

Pregnancy and Lactation: *THC should not be used during pregnancy. *Information regarding safety and efficacy of medical cannabis in pregnancy and lactation is lacking. In retrospective studies, cannabis had a modest effect on fetal growth.

THC is contraindicated in breast feeding. THC crosses the placental barrier and is excreted in breast milk. Men and women of childbearing potential should use contraceptive precautions for the duration of therapy with medical cannabis and for three months after discontinuation of therapy.

* Florida law prohibits the use of THC but allows CBD (low-THC) in pregnant patients with a physician certification.

Relative contraindications: Severe cardiovascular, immunological, liver, or kidney disease, especially in acute illness. Cannabis may exacerbate arrhythmia or a history of arrhythmias. The benefits versus risks of the use of cannabis extracts should be carefully weighed in individuals with psychosocial disorders.

Eating grapefruit or drinking grapefruit juice affects how your body processes certain medications. The chemicals in grapefruit can cause your body to absorb either too much or not enough medication into your bloodstream. If you don’t know if the medication you are taking interacts with grapefruit, ask your doctor or pharmacist. Not all medications interact with grapefruit, but many commonly prescribed medications do. Examples include medicines to treat High cholesterol (Lipitor), High blood pressure, Heart arrhythmia, Depression and anxiety, Human immunodeficiency virus (HIV), Organ transplants, Allergies (Allegra), Erectile dysfunction.

Warnings and Precautions Precautions: This product may have intoxicating effects. Do not drive or operate heavy machinery while under the influence of cannabis. Cannabis has additive CNS depressant effects with alcohol, barbiturates and benzodiazepines. Simultaneous use of these compounds with oral Δ9-THC (the major active ingredient of cannabis) may reduce the performance of psychomotor tests, suggesting that those who use any of these drugs together with medical cannabis could expect the effects to be additive. Precaution should be exercised when driving or operating machinery. Due to the possible disruption in the normative neuromaturational processes that occur during adolescence, chronic cannabinoid exposure during adolescence, but not adulthood, may affect cognition later in life. The American Academy of Pediatrics recognizes exceptions should be made for compassionate use in children with debilitating or life-limiting diseases for whom current therapies are inadequate.

Drug Interactions: Few data are available regarding the potential drug interactions associated with cannabis. Nevertheless, predictions of potential interactions based on the known pharmacology of THC and CBD and some of your Liver Enzymes can be made.

Any combination with potential for interaction should be used with caution. Your physician should coordinate with other medical professionals involved in your care to determine if any of your medications interact with medical cannabis.

Following are some examples of medications that may interact with medical cannabis: • Alcohol (Ethyl): Central Nervous System (CNS) Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy. • Anticoagulants: THC and CBD may enhance the effects of anticoagulants (i.e. warfarin) and therefore may increase levels of INR. Monitor therapy. • Anticholinergic Agents: May enhance the tachycardic effect of Cannabinoids. Monitor therapy. • CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy. • Benzodiazepines: CBD may lead to increased blood levels of benzodiazepines (i.e. clobazam). Levels must be monitored, and dosage adjustments may be warranted. • Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy. • Sympathomimetics: Cannabinoids may enhance the tachycardic effect of Sympathomimetics. Monitor therapy. • Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Consider therapy modification.

Adverse Reactions Cannabis and its analogues are regarded as having a relatively positive safety profile, with mild adverse events common including headache, dry eyes, dry mouth, dizziness, light-headedness, numbness, and cough. Serious adverse effects are rare with cannabis or its constituents. Cannabis has low to moderate dependence potential and the active dose is very far below the lethal dose.

THC has been associated with a number of side effects including anxiety, cholinergic deficits, and immunosuppression. THC can produce psychoactive effects that may not be well tolerated in some patients. Patients who are less experienced with cannabis tend to demonstrate more frequent side effects. Cannabinoids often work best in conjunction with other cannabinoids. Increases in plasma cortisol due to administered THC have been demonstrated and increases in heart rate, and both transient hypotension and increased systolic blood pressure have also been recorded.

CBD was found to potentially affect hepatic drug metabolism and possibly decrease fertilization capacity. In a study involving a pure CBD extract, the most common side-effects experienced were somnolence, decreased appetite, diarrhea, fatigue and convulsion.